BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER

    K Number: K954637 · Decision Dec 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    23
    Review Days
    83

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    Basic Information

    Device Name
    AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER
    K Number
    K954637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Dental Products, Inc.
    Date Received
    October 6, 1995
    Decision Date
    December 28, 1995
    Product Code
    EBI
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by American Dental Products, Inc.

    K Number Device Name
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    K973185 AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
    K964133 AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
    K954876 AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA
    K954406 AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE
    K954701 AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
    K954407 AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE
    K954408 AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE
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